Recall archive
453 recalls · page 2 of 19
Reported Apr 1, 2026
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions…
FDA (openFDA device enforcement)
Reported Mar 4, 2026
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached…
FDA (openFDA device enforcement)
Reported Feb 18, 2026
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Product details — Due a design issue where the navigated array connection geometry is incorrect.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting…
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may…
FDA (openFDA device enforcement)
Reported Jan 21, 2026
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical…
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume…
FDA (openFDA device enforcement)
Reported Dec 24, 2025
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't…
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
Matched: Reason for recall — The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards…
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand — There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CareLink Clinic, REF: MMT-7350
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based…
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological…
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Product · Product details — The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting…
FDA (openFDA device enforcement)
Reported Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand — The catheters may not retain their shape.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Due to out of the box wobble of the driver.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details — In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details · Reason for recall — A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
Matched: Brand — A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Azure S DR MRI SureScan, Product number W3DR01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand — Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential…
FDA (openFDA device enforcement)
Reported Jun 11, 2025Updated Aug 26, 2026
Medtronic recalls Newport™ Newport™ HT70 and HT70 Plus ventilators and certain related service parts due to Device & Drug Safety - Potential Defect
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Medtronic
Matched: Brand · Product — Device & Drug Safety - Potential Defect
FDA (recalls & safety alerts)
Reported May 7, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An…
FDA (openFDA device enforcement)
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